Endourethral device &amp; method

ABSTRACT

Embodiments of adjustable length intraurethral devices intended for patients with Lower Urinary Tract Symptoms (LUTS) are disclosed. These devices are to be placed within the human urethra and in communication with the bladder. Each device is easily adjustable to accommodate the prostatic length and sphincteric anatomy of the patient. Devices are stabilized in the urethra by two anchoring elements. The first anchor is fluid filled and positioned at the outlet of the bladder, and a second anchor is mechanical and is located at the bulbous urethra. These are separated by a structure which selectively supports a portion of the urethra from closing without restricting the portion of the urethra in the region of the external sphincter. These embodiments provide for the regulation of the flow of urine from the bladder by the natural control of the external sphincter when the user desires.

This is a continuing application filed under 37 CFR §1.53(b) of aregular application Ser. No. 10/059,100, filed Jan. 23, 2002 under 35U.S.C. §111(a) claiming priority under 35 U.S.C. §119(e)(1), ofprovisional application Ser. No. 60/263,202, having a filing date ofJan. 23, 2001; provisional application Ser. No. 60/295,535, having afiling date of Jun. 4, 2001; and, provisional application Ser. No.60/329,859, having a filing date of Oct. 18, 2001, all of which werefiled pursuant to 35 U.S.C. §111(b), each of which being incorporatedherein by reference.

TECHNICAL FIELD

The present invention generally relates to medical devices, moreparticularly to endourethral devices, and still more particularly toendourethral devices having anchor structures which permit the dischargeof urine therethrough and/or there around.

BACKGROUND OF THE INVENTION

Urinary problems can have serious consequences, particularly when theproblem is one of retention, incomplete emptying, or dysuria. Urine flowproblems include urine retention, incontinence, and difficult urination.Retention can result from any of a number of causes, including withoutlimitation, spinal cord injury, typhoid, peritonitis, prostaticenlargement, urethral stricture, urethritis, cystitis, bladder tumors,or urethral calculus. Patients suffering from these and other conditionsoften require some interventional means to periodically drain or augmentdrainage of the bladder. Failure to do so can result in damage of theepithelium and detrusor muscles associated with the bladder, and anincreased potential for bacterial invasion which is commonly thought tocontribute to urinary tract infection potentially leading tolife-threatening kidney failure.

Beyond notions of intervention, in roads are presently being made in thearea of office and office/home based monitoring of patients for purposeof diagnosing the contribution of the prostatic urethra to the outflowurodynamics. Differential diagnosis is understood by accepting thatthere are three primary anatomical organs which interact to contributeto the function of urination. First the bladder, second the urethra, andthird the sphincter(s). The prostatic gland surrounds the urethra in thevery short segment between the bladder, at its outlet, and the externalsphincter. When the patient experiences symptoms of bother which may bemade manifest in several independent or co-existing difficulties duringurination, treatment is often sought.

For example, bothersome symptoms might include: (i) incomplete emptying,(i.e., the patient is only able to urinate small volumes, e.g. <100milliliters (ml), or has an elevated volume of urine left in the bladderfollowing urination, e.g. >100 ml. per attempt); (ii) frequent urges tourinate (i.e., experiencing a frequent feeling of needing to urinate byan individual); (iii) intermittency (e.g. a patient's flow stops andstarts often during urination); (iv) has a very weak and inconsistenturine flow stream; (v) stress incontinence (e.g. leaking during liftingor straining as a result of excessive urine in the bladder or weakenedsphincters. With the exception of stress incontinence, each of these maycontribute to nocturia (i.e., poor sleep due to the repeated need tourinate during the night), yet a further symptom.

Up to two million office visits annually in the United States areattributed to patients being bothered by some form of lower urinarytract symptoms (LUTS). As previously noted, there are two primaryorgans, and the prostate, involved with the event of urination. Thesymptoms are virtually always suspected to be caused by the intrusion ofan enlarged prostate gland upon the urethra, however, symptoms are oftencaused by irregularities in bladder function, or sphincter deficiencies.For this reason, bladder outlet obstructions (BOO) is a major subgroupof LUTS. In men between the ages of 55 and 75 years, it is estimatedthat between 50 and 75% have some degree of bladder outlet obstruction,however, it may not be responsible for their symptoms.

Bladder outlet obstructions are primarily caused by the enlargement ofthe prostate gland (e.g., benign prostate hyperplasia (BHP)) whichresults in radial compression of the urethra surrounded thereby (i.e.,the prostatic urethra), thus obstructing (i.e., constricting) urineflow, resulting in incomplete emptying of the bladder (i.e., there beingwhat is clinically referred to as a “post void residual” (PVR) remainingin the bladder). Heretofore, males presenting with LUTS have fewdiagnostic options prior to either long term pharmacological, orinvasive irreversible medical procedures such as trans urethralresection of the prostate (TURP), or non-surgical procedures such asthermal treatment of the prostate.

It is well known within the urological community that significantnumbers of men undergoing treatment for prostate disease havesub-optimal results. According to Bruskewitz, BPH can be discussed interms of prostatic enlargement, outlet obstruction and LUTS. Jepsen J.V. and Bruskewitz R. C., Comprehensive Patient Evaluation for BenignProstatic Hyperplasia, 1998, Urology 51 (A4):13-18. In addition to theusual factors believed to lead to prostate induced LUTS (e.g., enlargedprostate and increased prostate muscle tone) other conditions of thelower urinary tract impact male voiding and need to be considered.Bruskewitz stated that a large part of the symptomotology of BPH mightbe explained by bladder dysfunction.

Bladder conditions that are prevalent in men with LUTS, eitherseparately or in combination with outlet obstruction, include detrusorinstability and detrusor hypocontractility. Kaplan S. A. and, Te A. E.,Uroflowmetry and Urodynamics, 1995, Urologic Clinics of North America 22(2):309-320. In a population of 787 men with symptoms of prostatism,Kaplan found that 504 (64%) had demonstrable prostatic urethralobstruction, of which 318 had concomitant detrusor instability. In thegroup, 181 had detrusor instability as their sole diagnosis. Impaireddetrusor contractility was present in 134 (17%) and 49 of these hadimpaired detrusor contractility as their only diagnosis. Bruskewitz andothers have also shown that a significant number of men with LUTS,including those who receive definitive treatment, are unobstructed.Abrams P., In Support of Pressure Flow Studies for Evaluating Men withLower Urinary Tract Symptoms, 1994, Urology 44 (2): 153-55. Patientsatisfaction rates after definitive prostate treatment vary from 100% to75% or less. In some cases the lack of success may be related tounidentified bladder dysfunction. Bruskewitz concluded that bladderdysfunction should receive more attention (in the evaluation andtreatment of LUTS) and better measures should be developed to quantifyit. Presently, urodynamic methods to assess bladder outlet obstructiongenerally include uroflow testing, pressure flow testing and generalpatient history/examination.

Uroflow testing provides information about the combined contribution ofthe detrusor and urethra to uroflow. The limitation of uroflow testingis that it is not possible to determine with certainty in all caseswhether a low flow and a poor voiding pattern are secondary to outletobstruction, detrusor hypocontractility or a combination thereof.Further, the test can be problematic because it is only a single eventthat can be influenced by patient factors such as anxiety andperformance of the test (i.e. direction of the urine steam into thecollecting reservoir). Abrams found that the success rate was only 70%when uroflow was used to select patients for surgery. Abrams P. H.,Prostatism and Prostatectomy: The Value of Flow Rate Measurement in thePreoperative Assessment for Operation. J. Urol 1977, 177:70-71.

Pressure flow testing can be used to define outlet obstruction and, inaddition, provides information about the contractility and performanceof the bladder. The pressure flow test, however, is not much moresuccessful in predicting success of treatment, as defined by thepatient, than uroflow (75% v 64%). Jepsen J. V. and Bruskewitz R. C.,Comprehensive Patient Evaluation for Benign Prostatic Hyperplasia, 1998,Urology 51 (A4):13-18. Therefore the urological community as well as theAgency for Healthcare Policy & Research (AHCPR) do not findjustification for its routine use.

Finally, the standard work-up of patients with LUTS being evaluated forbladder outlet obstruction generally consists of history and physicalexamination, including assessment of prostate volume, PSA, uroflowtesting, quality of life, and symptom and bother index. Based on theresults, treatment decision are made. Using these evaluations underlyingproblems with bladder function cannot be detected.

In lieu of traditional urodynamic test methodologies such as the use ofvideo urodynamics simultaneously with the holding and release of urine,cystometry, urethral pressure profiling, ultrasonic volume assessments(i.e., PVR), and uroflowmetry, each of which address the filing/emptyingconditions (i.e., dynamics) of the bladder, endourethral devices andaccompanying methodologies have been developed specifically to ascertainthe nature of the BOO. For instance by permitting the structures of thelower urinary tract to physiologically act in a sequential andincremental manner upon portions of a device during a naturalmicturition event, an observable change in fluid dynamics in furtheranceof lower urinary tract symptoms diagnosis may be noted.

Devices have been developed to be positioned in the urethra and/orbladder to correct the problems of urine flow. Problems anddisadvantages of heretofore known devices include the deleteriouseffects (i.e., pitting, depositions, etc.) associated with the urethralenvironment upon critical device components (e.g., valve actuators, flowconduits, etc.) which at a minimum render such devices less effective,and which at a maximum, cause device component failure or render thedevice wholly ineffective, which necessitates emergent removal and, asthe case may be, urinary tract damage repair. Problems of deviceleakage, or less than complete emptying of the bladder are also widelyknown. Furthermore, issues surrounding device deployment and fit,positioning, repositioning, and retention (i.e., sufficient anchoring)have also been well documented.

It is especially critical that the endourethral device be stable withrespect to position (i.e., a physiologically properly deployed andstable position), and comfortable to wear, as the urinary tract issensitive to contact. Inter-urethral stents have been utilized withinthe male urethra within the prostatic region with many users foregoingsuch devices for alternate therapies due to feelings of discomfortand/or pain. Many endourethral devices have similarly been evaluated forurinary incontinence for females. Based upon clinical findings, manyhave been shown to be uncomfortable, thus severely retarding theirutility as a therapy. Other devices have migrated into the bladder, orhave been expelled under straining conditions.

Furthermore, it is imperative that the device be no more invasive as isnecessary. For instance, it is advantageous that the device minimallyengage the structures of the lower urinary tract, particularly inaccomplishing an anchoring function. For example, it is well known thatsecretions of the prostatic urethra, including the Cooper's gland,whether during sexual function or otherwise, is clinically beneficial,the secretions are comprised, in part, of antimicrobial agents whichassist in the prevention of urinary tract infections. It is furtherbelieved that bathing of the bladder neck with urine assists infectionprevention. Generally, flow of urine external of an endourethral devicepermits the free passage of urinary tract fluids from the urethra asurine is released, thereby allowing a more physiologically normal urinedischarge. Thus, whether it be a short or long term endourethral device,for interventional, diagnostic or other purpose, stable anchoring incombination with physiologically proper, non-traumatic device deploymentand retention is essential.

SUMMARY OF THE INVENTION

The adjustable urethral device of the subject application, in all itsembodiments, enables a clinician to reduce inventory requirements, andallows for precise fitting to the patient's needs. Urologists areincreasingly finding great utility in fitting the patient accurately.This precise fitting will enhance the value of the use of lower urinarytract flow control apparatus. While adjustments have been described inseveral specific manners, it may be easily appreciated by those skilledin the art that adjusting either the threads which “span” the proximalelement and the tube, or the length of the proximal tubes, adjustmentsmay be accomplished which enhance the utility and methodology of the useof the device. Further, it may be appreciated that a fixed lengthproximal tube which passes through at least 40% of the prostatic urethracoupled with adjustable threads cooperatively will provide for asuitable device in many patients. It may be further appreciated thatwhen incorporating the previous applications, that a variable lengthflow around device may be easily accomplished when the proximal supportstructure which is analogous in anatomical location during use with thetubes may be enabled by either allowing it to telescope, or changing thethread lengths.

Accordingly, it is an objective of the invention to provide additionaldevice and procedural options for the care and diagnosis of patients whopresent to the urologist with lower urinary tract symptoms (LUTS).

For each user, there are two inter-dependent parameters which may beeasily measured in order to gain an increased understanding of thepatients urodynamic status. First, the post void residual (PVR).Increased PVR will occur when there is either hyperplasia (i.e.,thickening) of the prostatic gland, or a bladder that is not functioningproperly due to decompensation of the muscular function. Secondly, theflow rate of urine during emptying of the bladder is a strong indicatorof the function of the bladder when obstruction due to the prostate isnot present.

The device of all embodiments provides and allows patients to emptytheir bladders in a natural way and will assist in the reduction of PVRin patients with obstructed urethras due to an enlarged prostate if theprostate is the sole factor, as it often is. All embodiments providerelatively unrestricted passage of urine from the bladder to thatlocation. Simple placement of these devices allows for a urologist toeasily determine whether prostatic hyperplasia is the cause of the LUTS.

Each of the devices and methods of use are for individuals withsufficient bladder contractility, and offer a high probability ofreducing PVR. Reducing the PVR will in many instances further result inrelief from sleep deprivation and reduce the risk of full retention.This diagnostic utility is provided when the user has experience with anunobstructed prostatic urethra. The change in his symptoms will assistgreatly in confirming whether an enlarged prostate is the cause of hissymptoms. If the symptoms persist after the prostatic urethra issupported open, it is unlikely that he will benefit from atrans-urethral resection procedure (TURP), or alternative therapies. Inthis situation the source of his problems may be bladder or sphincterrelated.

The devices of these embodiments are easily placed into the patientwithout the necessity for external visualization such as rectal orabdominal ultrasound. Though these visualization methods are availableto the urologist or physician, it is undesirable to use them because ofcost and/or discomfort to the patient. The devices of all theembodiments may be installed in similar fashion to a Foley catheter bysimply inserting the device, inflating the proximal anchor, withdrawingthe device into the bladder outlet, and removing the insertion device.This provides further utility for a patient who is has excessivesymptoms of being obstructed, or is in danger of going into a state ofurinary retention due to use of drugs such as antihistamines, or havinghad a recent surgery.

Finally, the following U.S. patents, printed publications or provisionalapplications are noted, and incorporated herein by reference: 60/168,306(see U.S. Pat. No. 6,551,304); 60/179,038 (see U.S. Pat. Nos. 6,527,702,7,001,327); 60/223,345 (see US 2003/0208183 A1); 60/229,143 (see U.S.Pat. No. 6,719,709); 60/259,809; 60/263,202 (see US 2002/0107540);60/264,700 (see U.S. Pat. No. 6,719,709); 60/265,535 (see US2002/0107540); and, 60/299,973 (see US 2002/0198506 A1).

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 schematically depicts the human male urinary bladder and urinarypassage;

FIG. 2 illustrates an endourethral device of the subject invention,particularly showing “flow by” proximal and distal anchor systems;

FIG. 2A is a section view of the device of FIG. 2 taken about line2A-2A, more particularly, a sectional view of the proximal anchor ofsame;

FIG. 3 is a longitudinal cross section of an alternate embodiment of thedevice of the subject invention, the anchor elements in extension;

FIG. 3A is a section view of the device of FIG. 3 taken about line3A-3A, more particularly, a sectional view of the distal anchor of same;

FIG. 4 is a view of the device of FIG. 3, the anchor elements inretraction;

FIG. 5 illustrates an alternate embodiment of the endourethral device ofthe subject invention, particularly illustrating a distal mechanicalanchor, a proximal anchor element in extension;

FIG. 6 is a view of the device of FIG. 5, the proximal anchor element inretraction;

FIG. 7 illustrates an alternate embodiment of the endourethral device ofthe subject invention, particularly illustrating a distal mechanicalanchor along with a proximal anchor element in extension, lateral flowpermitted;

FIG. 7A is a section view of the device of FIG. 7 taken about line7A-7A;

FIG. 8 illustrates a side view of the device of a further embodiment;

FIG. 8A illustrates the device of FIG. 8 with the length adjusted andsecured;

FIG. 9 illustrates a side view of the device of yet a further embodimentwith the length adjusted and secured;

FIG. 10 illustrates a side view of an insertion/inflation tool employedin the introduction of the devices of the previous figures;

FIG. 11 illustrates the preparation of the proximal portion of theinsertion/inflation tool;

FIG. 11A illustrates the preparation of the distal extremity of theproximal tubular body;

FIG. 12 illustrates the preparation and loading of the distal anchorinto the insertion/inflation tool;

FIG. 13 illustrates the prepared assembly prior to insertion into theurethra;

FIG. 14 illustrates the distal portion of the insertion/inflation tool;and,

FIG. 15 illustrates a representative urethral device of the subjectinvention in situ.

DETAILED DESCRIPTION OF THE INVENTION

A schematic of the human male urinary bladder and urinary passage (i.e.,the lower urinary tract) is presented in FIG. 1. The bladder 30temporarily stores urine 32 and periodically expels it when the bladderneck 34 opens, as the bladder 30 contracts. Urine 32 passes through theprostatic urethra 36, which is completely surrounded by the prostate 38.The distal limit of prostate 38 is marked by a small projection calledthe verumontanum 40. This is a important landmark because distalthereto, is the external urethral sphincter 42, which relaxes soon afterthe urination process begins. Beyond this is the urethra 44, affording afree passage of urine 32 external to body, beyond the external urethralmeatus 46.

Generally referencing FIG. 2 (see also FIGS. 3, 5, and 7-9 havingreference numerals +600, +700, +800, +900, and +1000 respectively, forlike structures), there is shown an endourethral device 50 whichgenerally comprises an elongate member 52 having proximal 54 and distal56 segments, the elongate member 52 being positionable within the lowerurinary tract so as to at least partially traverse the prostaticurethra. A proximal anchor 58, adapted to preferably abuttingly engageportions of the bladder neck so as to at least proximally anchor thedevice, is supported at least indirectly by the proximal segment 54 ofthe elongate member 52. The proximal anchor 58 includes bladder engagingelements 60 radially extending from a portion of the proximal segment 54of the elongate member 52, urine being freely dischargable about atleast the proximal segment 54 so as to substantially bathe the bladderneck therewith. Preferably, but not necessarily, the bladder engagingelements 60 radially extending from a body 64 of the proximal anchor 58such that urine is freely dischargable about or around an exteriorsurface of the anchor body 64. A distal anchor 62, adapted to engageportions of the bulbous urethra so as to at least distally anchor thedevice, is supported by at least a portion of the distal segment 56 ofthe elongate element 52. The elongate member 52, may alternately beinterposed (FIG. 3), or at least indirectly extend (FIGS. 5 & 7) betweenproximal and distal anchor elements or structures, as will besubsequently described.

As may be apparent from the aforementioned description, it is to beunderstood that the configuration or overall structure of the elongatemember is highly variable, being dependent upon the sought afterfunctionality of the endourethral device (i.e., the physiologicalcondition being diagnosed and or treated). In an interventional setting,the elongate member generally provides a degree of support to assurepatency of an intact but contracted lumen, see for example published PCTApplication No. PCT/US01/24817 entitled ENDOURETHRAL DEVICE & METHOD,incorporated herein by reference (see WO 02/087412). Alternately, in adiagnostic setting for instance, the elongate member may comprise aselectively radial responsive segment for engagement with a portion ofthe urethra, namely the prostatic urethra. The radial responsive segmentor diaphragm possesses a dual functionality, namely selective inward andoutward radial responsiveness, in furtherance of qualitatively and/orquantitatively assessing fluid pressure and/or fluid flow throughportions of the lower urinary tract, and memorializing the nature of theurethral structures (i.e., the architecture of the prostatic urethra andthe relationship between the structures thereof) as by obtaining acasting, respectively, see for example, U.S. Pat. No. 6,719,709 entitledDIAGNOSTIC URETHRAL ASSEMBLY & METHOD, incorporated herein by reference,now U.S. Pat. No. 6,719,709.

Referring now to FIGS. 2 & 2A, the endourethral device (i.e., stent)shown includes a distal anchor 62 adapted to engage portions of thebulbous urethra, and a proximal anchor 58 adapted to abuttingly engagethe bladder neck, the anchors being linked by a support element orstructure 52. As aforementioned, form fits function relative to theelongate member or central segment of the endourethral device, in thisinstance a support element which includes a structurally supportive body66 which is preferably coil wound of 0.012 inch round stainless steelwhich has been silicone encapsulated. A fluid conduit 68, to facilitateexpansion of the reversibly expansive bladder engaging elements 60,distally extends along a longitudinal device axis from a fillingmanifold 70 to distal anchor 62. Emptying of the fluid system isaccomplished by removing a plug 72 from a drain port 74 integral to atleast the distal segment 56 of the elongate member 52, consistent withthe methodology and structures described in published application serialno. PCT US01/24817, previously cited.

A tensile member 76 preferably extends adjacent the support body 66,shown parallel with fluid conduit 68, but is not limited to sucharrangement. The tensile member 76 may extend directly adjacent fluidconduit 68, or alternatively, be wrapped around the perimeter thereof.As may be appreciated, the tensile member 76 may be surplusage (i.e.,redundant), being eliminated when fluid conduit 68 is sufficiently rigidor adequately reinforced. In the preferred architecture of this device,the tensile member is compressible along the longitudinal axis under arelatively light force, however, the tensile member may also beconstructed of a material which is relatively stiff axially such asstainless steel wire.

The proximal anchor 58 generally includes body 64 and bladder engagingelements 60 radially extending therefrom. In contradistinction toheretofore known bladder discharge aides, urine may be released from thelowest part of the bladder, often referred to as the bladder neck, urinebeing freely dischargable about/around an exterior surface of the body(i.e., a lateral flow condition) so as to substantially bathe thebladder neck.

The lateral urine flow path permitted by the proximal anchor, and thedistal anchor as will later be presented, is beneficial for severalreasons. First, the urine may more freely contact the bladder neck andbathe it. Second, the retained volume within the bladder is reducedfollowing a urination event. Third, an internal passageway does notlimit flow of urine to its boundaries. Urine may act in cooperation withthe urethra. This is important. As an individual ages, the bladderfunction may weaken as a result of prostatic obstruction, orindependently. The bladder micturition cycle is a work limited event.The muscle only contracts until it has spent the energy that isavailable to it. When the energy is spent, the muscles have tired, andwill stop contraction regardless of the volume of urine remaining inbladder. This remaining urine is referred to as the post void residual(PVR), giving rise to at least two further implications. A high PVRrequires a sooner return to the bathroom. If this is during sleepinghours, it will result in incomplete sleep and the deleterious effectsassociated therewith. Furthermore, a high PVR is widely viewed ascontributing to at least the susceptibility to urinary tract infections.

The bladder engaging elements 60 of the proximal anchor 58 areadvantageously circumferentially spaced apart about the surface of theanchor body 64. Preferably, but not necessarily, the engaging elements60 are opposingly paired (FIG. 2A), but need not be so limited. It isfurther advantageous that the bladder engaging elements 60 be resilient,and preferably, be reversibly expandable (e.g., the bladder engagementelements 60 may be opposingly paired balloons as depicted in FIG. 2/2A).Preferably, the bladder engaging elements 60 are torpedo shaped whenun-deflected by contact or otherwise unencumbered, this shapecontributing only a minimum of flow resistance when properly filled. Asis readily appreciated, low resistance is a critical consideration withrespect to proper stable device placement within the lower urinarytract.

The interface of the resilient bladder engaging elements 60 relative tothe anchor body 64, or proximal segment 54 of elongate member 52, alongwith the methodology and structure (i.e., insertion/filling tool) forreversibly deploying such endourethral device, or devices of this style,is generally disclosed in published PCT Application No. PCT US01/24817.Any modification or adaptation to accommodate the nature (i.e.,structural) of the contemplated endourethral device is considered withinthe skill of a person of ordinary skill in the art.

The proximal anchor 58 further includes at least a pair of urine flowchannels 78, each of the channels being defined or otherwise delimitedby adjacent bladder engaging elements 60, see especially FIG. 2A. Theurine flow channels 78 provide for high volumetric flow rates, andrelatively complete bathing of the urethra with urine (i.e., the notionof device flow about or around a/k/a lateral flow). Urine flow isinitiated when the external sphincter is dilated by the natural functionof the body at the users initiation. As will be later generally detailedwith respect to FIGS. 3-4, the distal anchor 62 may, as in the device ofFIG. 2, have elements, and interrelationships therebetween, whichsubstantially corresponding to those of the proximal anchor 58.

With continued reference to FIG. 2A, which illustrates the endourethraldevice in situ as viewed axially from proximal extremity 80, proximalanchor 58 secures the urethral device 50 from moving into the urethra(not shown in this view). The elongate member 52 may be advantageouslyprovided with a passageway or lumen 82 to allow for introductions offluids such as drugs, or antiseptics, or for filling the bladder by aninsertion/inflation tool. This optional passageway may be closed or openfollowing device insertion, however, it is preferable that the device ofFIG. 2 have a closed passageway following removal of insertion device,the closure limiting the area available for static urine to formencrustation.

Referring now to FIGS. 3/3A & 4, an endourethral device 650, similar ingeneral arrangement to that shown in FIG. 2 (i.e., having a commonproximal anchor feature and elongate member comprising a helical supportelement), is shown incorporating a distal flow around anchor mechanism662. The distal anchor 662 preferably, but not necessarily, includes abody 665 and urethral engaging elements 661 extending therefrom. Moreparticularly, the urethral engaging elements 661 are circumferentiallydisposed, in a spaced apart condition, about an exterior surface of thedistal anchor body 665, the elements 661 being radially extendibletherefrom. The distal anchor 662 further includes at least a pair ofurine flow channels 678, each of the channels 678 being delimited byadjacent urethral engaging elements 661. It should be readilyappreciated that anchoring of an endourethral device may besatisfactorily accomplished by a proximal segment 654, distal segment656, or a sharing of anchor function between each.

Endourethral device 650 has a proximal extremity 655 and a distalextremity 657. FIG. 3 illustrates device 650 having proximal anchormember 664 and distal anchor member 662 in a “filled” condition (i.e.,the anchor elements 660, 661 of the device are in extension) whereasFIG. 4 illustrates device 650 without fluid in proximal anchor member664 or distal anchor member 662 (i.e., the anchor elements 660, 661 ofthe device are in retraction). FIG. 3A is a centerline cross section ofdistal anchor member 662 of FIG. 3 illustrating filling conduit 668 influid communication with the interior of distal anchor 662. As may beappreciated, urine may easily flow adjacent distal anchor body 665within the bulbous urethra. This particular device 650 may be bestdescribed in four sequentially aligned zones, namely, moving distallyfrom the proximal end of the elongate member, zones I, II, III, and IV.

A passageway 682 extends through a first zone I from orifice 684 of theproximal end 654 of the elongate member 652. A second zone II, whichdwells in the prostatic urethra consists of an open structure, namely anopen pitched coil, which continues within a wall of the proximal portion654 of the elongate member 652, and terminates by or in unifiedconstruction or attachment to a tensile member 676 (zone II) whichfurther terminates in the distal zone IV containing anchor member 662.The tensile member 676 also converges or attaches to the extremity ofproximal segment 654 for safety. The internal fluid communicationbetween the first zone I and the distal anchor 662 is accomplishedthrough conduit 668 which is shown axially separate from tensile member676 though they are preferably in close proximity, or the same element.

The open structure of this endourethral device allows for the urine tocontact the wall of the urethra and flow along the urethra as it drains.This has the beneficial effect, as likewise achieved via the structureof FIG. 2, of allowing for the natural secretions from the prostaticgland into the urethra to participate in their natural environment.These secretions are known to be beneficial as natural infectioninhibitors as well as participating in sexual functions. Tensile member676 is preferably constructed of a silicone coated silk suture material,or alternatively of a more rigid material such as a coated stainlesssteel wire.

Referring now generally to FIGS. 5-9, a mechanical distal anchor 762 isillustrated for an endourethral device, more particularly a wing typestructure is shown tethered to an elongate member of an endourethraldevice. As emphasized throughout, a variety of devices mayadvantageously integrate the new anchor structures of the subjectinvention, singularly or in combination. For instance, the device ofFIG. 5 illustrates heretofore known proximal anchoring in combinationwith mechanical anchor 762. In this style device, a circumferentiallydisposed bladder (shown uninflated in FIG. 6) is carried about the outersurface of a proximal portion of the elongate member for fully engaginga portion of the bladder neck. Proximally of the proximal anchor, theproximal portion of the elongate member is adapted, as via the inclusionof an aperture or plurality of same, to receive urine for passageinteriorly of the elongate member (e.g., a tubular element). The deviceof FIG. 7 depicts an endourethral device having the flow around orlateral flow proximal anchor as shown and previously described withrespect to FIG. 2.

Referring again generally to FIGS. 5-9, the distal anchor 762 (FIGS. 5 &6, or 862 (FIG. 7/7A), 962 (FIG. 8/8A), 1062 (FIG. 9),) generallyincludes a body 765 having urethral engaging elements or portions 761extending or depending therefrom, or otherwise integral thereto. As isreadily appreciated by a review of the figures, the distal anchorelement 762 is of particularly low profile (i.e., an insubstantialhindrance to urine discharge), being reversibly expanded followingdeployment (e.g., by discharge from an insertion tool or the like). Themechanical anchor preferably tapers toward a distal end thereof, suchconfiguration aiding the retrieval of the mechanical anchor as will bediscussed.

The distal anchor member 762 preferably, but not necessarily, includes asilicone encapsulated spring strut 786, or particular arrangement ofstruts or strut segments, either directly or indirectly extending from acentral hub 788. When resiliently expanded, as for instance postdeployment, the struts 786 expand to discretely engage portions of theurethral wall. In the configuration of FIG. 7A, it is noted that aportion of the elongate member 852 possesses a cruciform cross-sectionresulting from radially extending circumferentially spaced apart ribs863.

Referring to FIG. 8, urethral device 950 is illustrated as an assembly.Urethral device 950 has a proximal extremity 955 and a distal extremity957. Near the proximal extremity 955 is a port 984. Balloon 960 islocated distal of port 984 on the extremity of tubular body 966. Asecond slidable tubular body 966 a is oriented around the outerperiphery of tubular body 966. In the subject embodiment, tubular body966 a is configured with at least one set of openings 969 a forregistration with a series of spaced apart openings 969 of tubular body966. The openings are provided for easy fixation of the tubular body 966a with the slidable tubular body 966 using suture 971 or the like tosecure the body elements.

Securing threads 977 are tied and encapsulated near the distal extremity957, and extend to the distal anchor 962. These threads may be providedeither pre-tied to provide a fixed initial length, or adjustable toprovide the physician the ability to adjust per his measuredrequirements. Distal anchor 962 is mechanical in nature, lackinginflatable components, compare with the embodiment of FIGS. 3/4. Itshould be easily and readily appreciated that this adjustment mechanismand technique may be imported to other endourethral devices, and moregenerally, other known indwelling medical devices.

The anchor 962 is expanded, as illustrated, following deployment viaencapsulated spring strut 963. When expanded, distal anchor 962 isapproximately semi-circular at its expanded perimeter, and triangularlongitudinally. Retrieval tether 993 is fixed to the distal extremity957. Retrieval suture 990 is further joined to drain tether 992, whichterminates in a drain plug 995, and removal tether 993. The mechanismand functions of the tethers are fully explained in the co-pendingapplications previously cited, and will not be further explained in thisdocument.

Urethral device 950 of FIG. 8A is shown fixed in length. When theslidable tubular body 996 a has been moved longitudinally along theextremity of tubular body 996 such that a select, proper length isachieved, securing is accomplished by looping suture 971 through thepassageway 969 a in the outer slidable tubular body 966 a, throughpassageways 969 in tubular body 966 and securing the suture ends. Thisresults in a fixation of the body length. Alternatively, the length maybe mechanically fixed using fasteners or mechanical retainers, as shownin U.S. Pat. No. 6,991,596, incorporated herein by reference. It may beappreciated that practicing urologists are also surgeons who are wellaccustomed to tying secure knots. For this reason, passageways 969 maybe optionally removed for certain models when the urologist chooses tomake his own passageways with a needle. This will not change the intentand or scope of this invention. Alternatively, the length may bemechanically fixed using fasteners or mechanical retainers such asclips, staples, or locking devices.

The tubular body 966 and the slidable tubular body 966 a are constructedfrom medical grade silicone material. These tubular bodies may becomprised of two separate tubular entities, or conversely singleprolapsing construction. The interior of both tubes may be optionallyreinforced to provide increased resistance to collapse. Suitablereinforcements include stainless steel coils or other means. The tubularbodies are preferably medical grade silicone or other suitable materialssuch as for example polyurethanes commonly used in urology applications.

Referring to FIG. 9, a further, non-limiting adjustable architecture isillustrated. Urethral device 1050 is illustrated with tubular body 1066,and second outer tubular body 1066 a. Urethral device 1050 is similar infunction to urethral device 950 (FIG. 8), with the variation in thattubular body 1066 a is configured with an internal helical pattern,which cooperates with tubular body 1066. The body length is therebyadjusted by rotating one of the tubular bodies relative to the other.

Like the previous embodiment, when the “slidable” tubular body 1066 ahas been moved longitudinally along the extremity of tubular body 1066such that a select, proper length is achieved, securing is accomplishedby looping suture 1071 through the passageways 1069 a in the outerslidable tubular body 1066 a, through passageways 1069 in tubular body1066 and securing the suture ends. This results in a fixation of thebody length.

The tubular body 1066 and the “slidable” tubular body 1066 a areconstructed from medical grade silicone material. The interior of bothtubes may be optionally reinforced to provide increased resistance tocollapse. Suitable reinforcements include stainless steel coils or othermeans.

Referring to FIG. 10, an insertion tool 200 is illustrated for deployingthe contemplated devices of the subject invention, with the combinationillustrated in FIG. 13. Insertion tool 200 has a proximal extremity 202and a distal extremity 204. Sealing rings 206 are intended to engage aninterior surface of the proximal portion of the device as will later beexplained. Anchor sleeve 208, which encapsulates a portion of elongatetube 210, restrains the distal anchor of the device within the interiorof the tubular housing 212, and adjacent push cup 213, during deviceinsertion or deployment. The elongate tube 210 is movable relative totube 214 which is advantageously lined with coil 216. This movement iscontrolled from the proximal extremity, more particularly, via needletip 218 of fluid filling port 219 as it is moved relative to barrelhandpiece 220.

The following instructions for use describe an advantageous clinical usesequence. Preliminarily, remove the packaged urethral device andinsertion/inflation tool; inspect the device and tool for damage; verifythat balloon plug of the device is in place; and, flush tool withsterile water or saline to remove any air therein.

With reference to FIG. 11/11A, lubricate the sealing ring area of thetool with lubricant, e.g., K-Y Jelly. Similarly lubricate the lumen ofurethral device, e.g., by injecting lubricant into distal end of theproximal tube. After lubrication, the tool, more particularly theproximal extremity thereof, may be inserted into the device's proximaltube portion until the proximal tip of the tool is fully seated into theproximal end of the device. For adjustable models, first determinedevice length and secure the tubes (i.e., tubular bodies) together toachieve a suitable length device. For non-adjustable models, select asuitably sized device.

Referring now to FIG. 12, following sterile preparation, retract theanchor sleeve or sheath of the tool so as to expose the push cupthereof. Hold the push cup, just distal of the anchor sheath, whileinserting the distal end of the distal anchor of the device into thepush cup. Note that the push cup is marked with a black indicator.Distal anchor end should be inserted so as to be positioned under theblack indicator.

Thereafter, the distal anchor of the device is collapsed and wrappedaround the shaft of the inflation tool. The wrapped distal anchor isthen pushed or more generally inserted into the anchor sheath of thetool until the anchor is completely housed in the sheath. The spacersleeve of the tool should abut the proximal end of the anchor sheath.The retrieval suture is then routed along the length of the tool.

In connection to device deployment, the device of the subject invention,in all its embodiments, is delivered in a similar fashion as a Foleycatheter of equivalent profile. Slowly advance the device, i.e., thecombination or assembly of FIG. 13, into the urethra, paying closeattention to the resistance felt in the vicinity of the externalsphincter. Do not use excessive force if unexpected resistance isencountered; do not continue without first determining the cause ofresistance. Once the entire length of the assembly has been advanced,the proximal end of the device of the assembly will be in the bladder.Using a luer syringe, “inflate” the balloon of the proximal deviceportion via the needle tip of the inflation port with about 5 cc ofsterile water or saline, at a rate of approximately 1 cc per second.Filling rates in excess of 1 cc/sec may result in incomplete balloonfilling.

Positioning of the urethral device is accomplished by applying gentletraction to the tool using the inflation port (FIG. 14). Do not pull onthe sheath hand piece. Pulling on the sheath hand piece may causepremature deployment of the distal device anchor. After resistance isfelt, assuring that the now expanded proximal device balloon ispositioned in/at the bladder neck, retract the anchor sheath by pullingon the sheath hand piece while holding the inflation port stationary.Pull the sheath hand piece until it stops sliding (i.e., sheath travelis approximately 1 inch or 2.5 cm), thereby indicating full sheathretraction.

Thereafter, apply gentle traction to the tool to “undock” (i.e.,release) it from device, and then completely withdraw it from theurethra. The retrieval suture, color coded, may then be trimmed to anappropriate length such that the distal end is just inside the meatus(reference the deployed device of FIG. 15). Finally, the patient is tobe instructed not to pull or otherwise manipulate the exposed/accessibleportion of the tether as such action could “deflate” the distal deviceanchor, and dislodge the urethral device or cause expulsion of same.

As should be appreciated in connection with FIG. 15, and with referenceto the device embodiments of FIGS. 8 & 9, in order to achieve theoptimal treatment or therapy, an appropriate length device must beselected to accommodate the patients anatomical requirements. To sizethe device, measure the length of the prostate gland adjacent to theurethra. Careful measurement will help assure a properly fitting device.Other methods, such as direct measurement of the prostatic urethralength with inserted catheter-devices, can be used, if available, andtransrectal ultrasound (TRUS) may likewise be utilized for such purpose.Finally, device of U.S. Pat. No. 6,719,709 are likewise suitable, andadvantageous.

Using the prostatic urethra length, measured in centimeters (cm), matchthe measurement to the range defined in Column A of Table 1 herewith.Follow the row across to select the appropriate urethral device size inColumn D. TABLE 1 Urethral Device Size Selection Table Column A TRUSColumn C Measurement Prostatic (Prostatic Stent Length Column D UrethraColumn B (Reference Urethral Length) UMD Measurement only) Device Size<2.4 <4 2.4 4 2.5 to 3.0 4.1-5.0 3.0 5 3.1 to 3.6 5.1-6.0 3.6 6 3.7 to4.2 6.1-7.0 4.2 7 4.2 to 4.8 7.1-8.0 4.8 8 4.8 to 5.4 8.1-9.0 5.4 9

Generally, if the prostate length measurement exceeds 5.4 cm, thepatient may not be a candidate for a urethral device, with deviceselection and insertion at the discretion of the physician, depending onthe length of the obstructed region, adequate overall device size, andplacement in the prostate anatomy.

As to preferred materials of construction, the endourethral devicegenerally, but not necessarily utilizes a core construction of a 304stainless steel wire coil encapsulated using implant grade siliconerubber (shore 30A, Rhoda Silicones, Inc., Ventura, Calif. PN V40029A &V40029B) to form a prostatic urethral stent. The proximal anchor of thedevice is bonded to the prostatic stent portion of the device. Bondingan anchoring balloon to a cast proximal tip forms the proximal anchor.The proximal tip is cast from silicone rubber (Rhoda Silicones). Theanchoring balloon is extruded using an implant grade silicone rubber(NuSil Technology, Carpenteria, Calif., PN MED-4720), with the balloonbeing bonded using silicone adhesive (NuSil Tech. PN MEDl-4213).

The distal anchor is formed in the same fashion as the proximal anchor;a balloon is bonded to a distal anchor manifold. The proximal anchor anddistal anchor are connected via an inflation lumen which is a medicalgrade silicone rubber tube (SF Medical, Hudson, Mass.; PN SFM3-1350)possessing a 0.020″ internal diameter and a 0.009″ wall thickness. Thetube is attached to each anchor using silicone adhesive. The distalanchor manifold provides the location for receiving the drain plug ofthe anchoring balloons. The drain plug is formed from 304 stainlesssteel hypodermic tubing bonded/sealed to a size 1/0 silk suture usingmedical grade epoxy (TRA-CON, INC., Bedford, Mass.; PN TRA-BOND FDA2).When the plug is pulled from the distal anchor manifold port both theproximal and distal anchoring balloons deflate.

The device preferably uses a retrieval suture formed by size 1/0 silksuture, which is attached both to the distal end of the distal anchorand the distal end of the prostatic stent section. The retrieval suturetraverses the length of the prostatic stent and attaches to the proximalend of the stent thereby limiting the amount of stent extension undertension. The use of silk provides flexibility due to its multiple strandconstruction while maintaining an acceptable break load limit.

The endourethral device may been fabricated in various lengths rangingfrom about 4 to 9 cm, the length measured from the distal end of theproximal balloon to the proximal end of the distal balloon. The ratio ofthe length of the prostatic stent to the remaining length (i.e., thelength spanning the external sphincter) may be varied, presently thelength ratio is 3:2 (i.e., for a 5 cm length device, the prostatic stentlength is 3 cm). The external profile of the device may be fabricatedfrom 10 French to 32 French.

This invention disclosure provides device configurations which achieve asought after anchoring function and methodology. There are othervariations of this invention which will become obvious to those skilledin the art. It will be understood that this disclosure, in manyrespects, is only illustrative. Changes may be made in details,particularly in matters of shape, size, material, and arrangement ofparts without exceeding the scope of the invention. Accordingly, thescope of the invention is as defined in the language of the appendedclaim. As will further be appreciated, it is contemplated that theanchoring configurations of the subject invention be readilyincorporated into known endourethral devices for diagnosis, managing ortreating urological disorders, the benefits thereby accruing thuslybeing available generally to patient's presenting with such disorders.

1-21. (canceled)
 22. An endourethral stent adapted to deliver aneffective amount of therapeutic agent to a lower urinary tract, theendourethral stent comprising a proximal anchor structure forcooperative engagement with a bladder neck so as to prevent devicemigration toward a bulbous urethra, a distal anchor structure forcooperative engagement with at least portions of the bulbous urethra soas to prevent device migration toward the bladder, a selectivelydimensionable body for selectively fixing a dimension corresponding to adistance between said proximal and distal anchor structures, said bodyincluding a segment adapted to permit physiological external sphincterfunction.
 23. The endourethral stent of claim 22 further comprisingmeans for selectively fixing said selectively dimensionable body of saiddevice.
 24. The endourethral stent of claim 22 wherein said distalanchor structure is non-rigidly linked to a portion of said selectivelydimensional body.
 25. The endourethral stent of claim 22 wherein saiddistal anchor structure non-rigidly extends from a portion of saidselectively dimensional body.
 26. The endourethral stent of claim 22further comprising a non-rigid linkage, said non-rigid linkageconnecting said distal anchor structure to a portion of said selectivelydimensional body.
 27. The endourethral stent of claim 26 wherein saidnon-rigid linkage comprises a single suture.
 28. The endourethral stentof claim 26 wherein said non-rigid linkage comprises a configuration ofmultiple sutures.
 29. The endourethral stent of claim 26 wherein saidnon-rigid linkage includes a free end terminating at a retrieval tetherof said stent.
 30. An endourethral device adapted to deliver aneffective amount of therapeutic agent to a lower urinary tract, theendourethral device comprising a proximal anchor structure adapted toabuttingly engage at least portions of a bladder neck so as to at leastproximally anchor said device, a selectively dimensionable bodyextending from said proximal anchor, and a distal anchor structuretethered to said body for engagement with a bulbous urethra.
 31. Theendourethral device of claim 30 wherein said body is longitudinallycompactable.
 32. The endourethral device of claim 31 wherein said bodyincludes proximal and distal portions.
 33. The endourethral device ofclaim 32 wherein said portions of said body are adapted for cooperativeengagement.
 34. The endourethral device of claim 32 wherein saidportions of said body are selectively securable to each other.
 35. Acatheter apparatus comprising an endourethral stent assembly and aninsertion tool slidably receivable within a portion of said endourethralstent assembly, said endourethral stent assembly comprising a proximalanchor structure adapted to abuttingly engage at least portions of abladder neck so as to at least proximally anchor said stent subsequentto delivery, a selectively dimensionable body extending from saidproximal anchor, and a distal anchor structure tethered to said body forengagement with a bulbous urethra subsequent to delivery.
 36. Thecatheter apparatus of claim 35 wherein said insertion tool includes atubular element translatable within a sheath, said tubular elementhaving a proximal extremity adapted to deliver fluid to a proximal endportion of said endourethral stent assembly.
 37. The catheter apparatusof claim 36 wherein said proximal extremity of said tubular elementincludes sealing rings for cooperative engagement with a proximal endportion of said endourethral stent assembly.
 38. The catheter apparatusof claim 36 wherein said proximal anchor structure of said endourethralstent assembly includes at least a single fluid fillable element. 39.The catheter apparatus of claim 38 wherein said sealing rings of saidtubular element traverse a fluid filling port of said at least a singlefluid fillable element.
 40. The catheter apparatus of claim 36 whereinsaid selectively dimensionable body of said endourethral stent assemblyis translatable upon said proximal extremity of said tubular element,and said distal anchor structure of said endourethral stent assembly isreversibly retained in a proximal extremity of said sheath.
 41. Thecatheter apparatus of claim 40 wherein said proximal extremity of saidsheath includes a push cup, at least a portion of said distal anchorstructure of said endourethral stent assembly confined thereby.
 42. Ancatheter apparatus comprising an endourethral device, a retrievalsystem, and an insertion tool, said endourethral device comprising astent body having a proximal fluid fillable anchor supported thereby, anexpandable mechanical anchor non-rigidly linked to said stent body, saidproximal fluid fillable anchor adapted to receive fluid via saidinsertion tool in furtherance of anchoring said device at a bladderneck, said retrieval system comprising a non-rigid tether having a firstand second segments, said first segment terminating in a plug receivedby said fluid fillable anchor, said second segment passing through aportion of said device.